粒细胞集落刺激因子(G-CSF)联合粒细胞-巨噬细胞集落刺激因子(GM-CSF)与单用G-CSF动员外周血干细胞的随机对照研究:对大剂量化疗后造血恢复的影响
Randomized comparison of G-CSF + GM-CSF vs G-CSF alone for mobilization of peripheral blood stem cells: effects on hematopoietic recovery after high-dose chemotherapy.
作者信息
Spitzer G, Adkins D, Mathews M, Velasquez W, Bowers C, Dunphy F, Kronmueller N, Niemeyer R, McIntyre W, Petruska P
机构信息
Saint Louis University Health Sciences Center, Department of Internal Medicine, MO, USA.
出版信息
Bone Marrow Transplant. 1997 Dec;20(11):921-30. doi: 10.1038/sj.bmt.1700999.
Fifty patients with either lymphoid or selected solid tumor malignancies were apheresed an identical number of times for PBSC collection after being randomized to receive either G-CSF 10 microg/kg/day alone (arm I), or G-CSF at the same dose with GM-CSF 5 microg/kg/day (arm II). Growth factor(s) was/were given as the stem cell mobilizing agent for 5 days before the start of PBSC collection, and were continued throughout the 4 days of apheresis. Aspiration and cryopreservation of autologous bone marrow occurred on day 3 or 4 of growth factor(s). Thirty-one of 50 patients received one cycle only at time of evaluation, and 19 patients received two cycles of HDCT, each supported with PBSC with or without autologous bone marrow. No patients received growth factors post-autologous stem cell transplant, unless the absolute neutrophils count (ANC) failed to recover to > or = 100/microl by day +18 post-transplant. The median number of days to recovery of ANC to 100/microl, 500/microl and 1000/microl, and of platelet counts to 20000/microl, 50000/microl and 100000/microl after either cycle 1 or cycle 2 of HDCT and the number of febrile days and platelet and PRBC transfusion requirements was not significantly different between the two arms of the study. The duration of hospitalization was similar between study arms for cycle 1 of HDCT, but was 3.5 days less with arm II compared to arm I (P = 0.0248) for cycle 2 of HDCT. The bone marrow buffy coat and PBSC product mononuclear cell count (x 10(8)/kg) and CD34+ cell count (x 10(6)/kg) collected by each method of stem cell mobilization was not significantly different. There is questionable clinical benefit with PBSC products mobilized with the combination of G-CSF and GM-CSF vs G-CSF alone. Perhaps different dosages, schedules, or other growth factor combinations with G-CSF might enhance these differences.
五十例患有淋巴系统恶性肿瘤或特定实体瘤恶性肿瘤的患者被随机分为两组,一组接受单独使用10微克/千克/天的粒细胞集落刺激因子(G-CSF)(I组),另一组接受相同剂量的G-CSF联合5微克/千克/天的粒细胞-巨噬细胞集落刺激因子(GM-CSF)(II组),之后两组患者均进行相同次数的单采以收集外周血干细胞(PBSC)。在开始采集PBSC前5天,给予生长因子作为干细胞动员剂,并在整个4天的单采过程中持续使用。在给予生长因子的第3天或第4天进行自体骨髓的采集和冷冻保存。50例患者中,31例在评估时仅接受了一个周期的治疗,19例接受了两个周期的大剂量化疗(HDCT),每个周期均采用PBSC支持,部分患者还联合了自体骨髓。除非自体干细胞移植后第18天绝对中性粒细胞计数(ANC)未恢复至≥100/微升,否则患者在自体干细胞移植后不再接受生长因子治疗。在HDCT的第1周期或第2周期后,两组患者ANC恢复至100/微升、500/微升和1000/微升的中位天数,以及血小板计数恢复至20000/微升、50000/微升和100000/微升的中位天数,还有发热天数、血小板和红细胞悬液输注需求,均无显著差异。HDCT第1周期时,两组患者的住院时间相似,但HDCT第2周期时,II组患者的住院时间比I组少3.5天(P = 0.0248)。两种干细胞动员方法所采集的骨髓血沉棕黄层和PBSC产品中的单个核细胞计数(×10⁸/千克)及CD34⁺细胞计数(×10⁶/千克)无显著差异。与单独使用G-CSF相比,联合使用G-CSF和GM-CSF动员的PBSC产品的临床益处存疑。或许不同的剂量、给药方案,或与G-CSF联合使用的其他生长因子组合可能会增强这些差异。